The Evolution of the Enablement and Written Description Requirements under 35 U.S.C. 112 in the Area of Biotechnology

Abstract

This Comment focuses on the current trend of the Federal Circuit to heighten both the enablement and written description requirements for biotechnological inventions under 35 U.S.C. § 112. It explores the history of the enablement requirement through a series of opinions by the Federal Circuit and the evolution of this requirement in case law. The Federal Circuit has interpreted the enablement requirement such that it is not satisfied if undue experimentation is required to practice the claimed invention. Likewise, the use of a heightened written description requirement by the Federal Circuit requiring the use of exact nucleotide sequences, allows definition and limitation of the scope of claimed genetic inventions. An analysis of the Revised Interim Guidelines on the written description requirement recently issued by the PTO is also made, concluding that the Interim Guidelines are not entirely consitent with the trend set forth by the Federal Circuit. The Comment suggests that although the Federal Circuit has been repeatedly criticized for the standards it has set in the area of biotechnology, to date the court's analysis has been reasoned and has solved many problems involving the potential for overly broad patents in this complex field. It argues that this approach is workable and concludes that the power of biotechnology to benefit humankind will withstand the disadvantages that it suffers under the current patent system.